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K Number
K030031
Device Name
SOFT TISSUE ANCHORING WASHERS
Manufacturer
ACCU-SPEED, INCORPORATED
Date Cleared
2003-01-28

(25 days)

Product Code
KGS
Regulation Number
878.4930
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Soft Tissue Anchoring Washers [washers], [washer, bolt nut] Indications For Use: are to be used for anchoring soft tissue to bone.

Device Description

Soft Tissue Anchoring Washers [washers], [washer, bolt nut]

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for a device called "Soft Tissue Anchoring Washers." It is a regulatory letter determining substantial equivalence to a predicate device.

The provided text does not contain any information regarding clinical studies, acceptance criteria, or performance data of the device. It is a regulatory approval letter, not a device study report. Therefore, I cannot extract the requested information.

§ 878.4930 Suture retention device.

(a)
Identification. A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.